New Data Suggests Less Abuse-Related Effects For OROS® Methylphenidate

Stimulant drug abuse remains an ongoing concern for parents and physicians who prescribe medications to treat Attention Deficit Hyperactivity Disorder (ADHD). Data presented today at the 160th Annual Meeting of the American Psychiatric Association highlighted findings that long-acting OROS® methylphenidate had fewer reports of abuse and lower abuse-related effects compared with other long- and short-term stimulant medications for ADHD.


The unique, long-acting OROS® methylphenidate formulation initially releases the drug, followed by a more gradual release of the remaining dose in an ascending pattern, compared with an immediate-release, or short-acting, methylphenidate formulation. The data presented today from two sources a national review of emergency department visits and a pharmacokinetic/pharmacodynamic study highlights a possible benefit related to reduced abuse potential that may be associated with the OROS® methylphenidate formulation.


"Although methylphenidate is proven to be an effective treatment for ADHD, some physicians may have concerns about the drug due to its abuse potential," said John J. Coleman, Ph.D., president of Prescription Drug Research Center. "Most patients take prescription medications responsibly, however, recent reviews still show that illicit stimulant use among adolescents in the United States remains a concern for physicians, parents and the general public."


About The Data


Drug Abuse Warning Network (DAWN) Review of Drug-Related Emergency Department Visits Among ADHD Treatments (APA Poster Board NR526)


DAWN data, a national health surveillance system that monitors drug-related emergency department visits, was used to examine emergency department visits resulting from the abuse of ADHD medication during a three-year period. The medications evaluated included OROS® methylphenidate, other methylphenidate formulations, non-methylphenidate stimulants, and non-stimulant atomoxetine.


A review of this data found that OROS® methylphenidate had a lower frequency of emergency department reports of abuse compared to other methylphenidate formulations. Furthermore, DAWN found that of all ADHD treatments, non-methylphenidate stimulants (e.g., amphetamines, mixed amphetamine salts) had the most emergency department reports of abuse.


The DAWN data highlights the "abuse-to-prescribed-use" ratio of ADHD drugs, in which OROS® methylphenidate was lower than that of other methylphenidate formulations, and similar to that of atomoxetine. The study found the highest abuse-to-prescribed-use ratio among non-methylphenidate stimulant formulations.1 (The abuse-to-prescribe-ratio was determined by dividing reported emergency department visits for abuse by the number of prescriptions dispensed for each type of ADHD drug during the three-year period.)


Overall findings showed that of the 1,102 reports of abuse gathered, long-acting OROS® methylphenidate had the least number of reports (89), compared with other long- and short-acting methylphenidate formulations (301), and non-methylphenidate stimulants (651). Only the non-stimulant drug, atomoxetine, had a lower number of overall reports at 61.















Pharmacokinetics and Pharmacodynamics of Abuse Potential (APA Poster Board NR525)


The other data presented today found that long-acting OROS® methylphenidate produced lower abuse-related subjective effects compared to immediate-release methylphenidate at comparable total doses. In this double-blind, placebo-controlled, randomized, crossover study, 49 occasional stimulant-abusing adults were given 50 mg and 90 mg doses of immediate-release methylphenidate and 54 mg and 108 mg doses of OROS® methylphenidate. The long-acting OROS® methylphenidate formulation releases drug in a more gradual pattern compared with an immediate-release methylphenidate formulation.


Researchers were able to determine the direct effect on the subjects' perception and enjoyment of the medications tested, drug-liking features that are thought to be associated with a medication's potential for abuse. At comparable doses, abuse-related effects were lower when subjects received the OROS® methylphenidate formulation.


Pharmacodynamics of potential abuse were assessed with Visual Analog Scales (VASs). The magnitude of scores on the VAS scales was ranked (lowest to highest) as placebo< OROS® methylphenidate (MPH) 54 mg, < OROS® MPH 108 mg,